Bipartisan FDA user fee advances

The “must-pass” Food and Drug Administration user fee bill was sent to the full House Energy and Commerce Committee on Tuesday morning on a raft of blown kisses from Democrats and Republicans on the Health Subcommittee.

After more than a year of work, at least 10 hearings related to user fees and “intense negotiations as recently as last weekend,” Joe Pitts (R-Pa.), chairman of the subcommittee said its members praised their staffs and one another and passed the bill by unanimous voice vote. It took less than a half-hour.

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The Energy and Commerce Committee will mark up the bill Thursday. Backers hope to move it to the floor quickly with the goal of getting it wrapped up — or very close to final — before the Supreme Court rules on the health law in late June. Industry sources worry the fallout from the ruling, no matter how it goes, could politicize the otherwise relatively bipartisan legislation and slow down, if not derail, its passage.

The user fee legislation would allow FDA to collect fees from the pharmaceutical and medical device industries to partially fund the agency’s efforts to clear new medical products for market and, to a far lesser extent, monitor them while they are being sold. This year’s package also includes a similar arrangement for the first time with generic drugmakers and those who are developing biologics, a relatively new and complex class of protein-based drugs.

It wasn’t clear Tuesday when the full Senate will consider its version of the user fee legislation, which the Senate Health, Education, Labor and Pensions Committee passed in a similarly bipartisan fashion last month. Over the weekend, industry and consumer sources and some congressional staffers thought the bill could come to the floor late this week, but a Democratic staffer said Tuesday that it probably won’t come up until next week.

Pitts, with the support of subcommittee ranking member Frank Pallone (D-N.J.), offered an amendment that made what the two lawmakers agreed were “technical revisions” based on recommendations from FDA and stakeholders over the weekend. The revisions made no substantive policy changes to the draft version posted Friday, Pitts and Pallone said.

Otherwise, no amendments were offered.

Energy and Commerce Committee Chairman Fred Upton (R-Mich.) gave the bill his blessing during a brief appearance, signaling that he intends to run a clean markup by the full committee Thursday. He said the legislation was “on track” to be enacted by the end of June, his long-stated goal.

But not everything is settled. The House bill includes incentives for antibiotic drug developers, including five years of extra protection from generic drugmakers, which is much more generous than the Senate version, which restricts the incentives to drugs that treat “serious and life-threatening” conditions.

Rep. Henry Waxman (D-Calif.) said it was no secret that he continues to have concerns about the Generating Antibiotic Incentives Now Act.

“I regret that we failed to narrowly tailor the bill,” Waxman said, adding, “As the bill stands now, essentially any antibiotic qualifies” for the incentives.

One of a handful of relatively small but substantive differences will have to be sorted out between the House and Senate.

And consumer groups, including Consumers Union, are still pushing for the inclusion of a provision proposed by Rep. Ed Markey (D-Mass.) that would allow FDA to reject applications for medical devices based on their similarity to defective devices that have been recalled from the market. But that language was not included in the Senate version, either.

But the markup couldn’t have been more cordial — quite a contrast to the recent mood of the House. Waxman said development of this bill “should be a model for legislative action,” and heads nodded all around.